Acute Coronary SyndromePhase 3NCT00243516
Trial for the Use of Pretest Probability to Reduce Unnecessary Testing for Low-Risk Patients With Chest Pain
A Phase 3 study testing PREtest Consult in people with Acute Coronary Syndrome, run by PREtest Consult at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if the implementation of quantitative pretest probability assessment will significantly reduce the unnecessary use of the intra-emergency department chest pain center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- PREtest Consult
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Oct 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emergency department patients aged > 17 who report a history of torso or arm discomfort within the past 24 hours.
- Physician orders an electrocardiogram and serum troponin measurement.
- Physician has undergone a 10 minute explanation session and has provided consent
Who cannot join
- 12-lead electrocardiogram (ECG) with ST deviation or T-wave changes that are interpreted by clinician as indicative of acute infarction or ischemia
- "Code STEMI" patients (patients with suspected acute myocardial infarction).
- Other primary diagnosis mandating admission (e.g., pneumonia, diabetic ketoacidosis, trauma)
- Patients with myocardial infarction, intracoronary stent placement, or coronary artery bypass grafting within the previous 30 days.
- Evidence of circulatory shock (SBP [systolic blood pressure] < 100 mmHg with symptoms defined by Jones)
- Cocaine use within the past 72 hours.
Show all 9Show fewer
- A moderate to high-risk composite clinical picture that causes an emergency medicine specialist to consult a cardiologist.
- Homelessness, out-of-town residence or other condition known to preclude follow-up.
- Prisoners and pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Carolinas Medical Center
Charlotte, North Carolina, 28203
Jane A Kilkenny, BA, 704-355-3975, jane.kilkenny@carolinashealthcare.org
William B Webb, BSPH, 704-355-0602, bwebb@pretestconsult.com
About this study
Official title: Randomized, Controlled Trial for the Use of Pretest Probability to Reduce Unnecessary Testing for Low-Risk Patients With Chest Pain
The purpose of this study is to evaluate if the implementation of quantitative pretest probability assessment will significantly reduce the unnecessary use of the intra-emergency department chest pain center. Specifically, the study will examine whether the PREtest Consult acute coronary syndrome (ACS) pretest probability assessment system can significantly reduce the use of chest pain unit evaluation in very low risk emergency department (ED) patients, can safely discharge patients with a pretest probability ≤ 2.0%, can reduce unnecessary procedures and lower hospital costs and will examine patient satisfaction of patients with whom pretest probability assessment was used compared to those with whom it was not used.
The researchers hypothesize that patients in the control group of the study will have statistically significant reductions in mean time spent in the emergency department, mean charges billed to the patient or their insurance carrier, hospital length of stay, mean number of procedures or tests performed without a statistically significant change in patient satisfaction or adverse outcome.
Read the detailed description
Chest pain represents the second most frequent complaint among the 110 million persons who visit emergency departments in the U.S. each year. Perceived medicolegal risk compels emergency physicians to overtest for possible acute coronary syndrome (ACS), contributing to more than $20 billion in unnecessary diagnostic testing each year. The hypothesis of the present work states that quantitative pretest probability assessment can significantly and safely increase the proportion of very low risk patients with symptoms of ACS who are discharged from one emergency department. Quantitative pretest probability will be assessed with the validated, commercially available PREtest Consult ACS software device, which employs computer assisted, attribute matching. This method matches an 8-component clinical profile from any individual patient to the same profile shared by patients who were previously evaluated for ACS and whose profiles are stored in a 14,800 patient reference database. Pretest probability estimates ≤ 2% will be considered "test negative." A phase II multicenter study found that when the ACS PREtest Consult produced a pretest probability of ACS ≤ 2.0% that the actual outcome of ACS at 45 days was 0.3% (95% CI 0 to 1.8%) compared with 0.4% (0 to 0.9%) for patients discharged after negative testing in a chest pain unit (CPU) that included serial biomarkers, overnight monitoring, and cardiologist-interpreted provocative testing. Over one-quarter of all patients referred to the CPU had an estimate ≤ 2%. The present study will randomize 400 ED patients with a non-diagnostic or normal ECG and a troponin test ordered into two groups:
- a "show me", or disclosure group, in which patients and their clinicians will receive the output of the device, and
- a "no show" or concealed group will receive no output.
The sample size will detect an 11.5% difference in rate of discharge between groups with α = 0.05 and β = 0.20. All discharged patients will undergo structured telephone and medical record follow-up at 7 and 45 days using validated methodology.
Primary outcome measures will evaluate the development of acute coronary syndrome.
Secondary variables will include:
- Frequency of ACS, determined by blinded adjudicated review of follow-up data,
- Rate of return to any ED for similar symptoms,
- Patient satisfaction,
- Charges.
Project significance includes the potential to reduce patient exposure to unnecessary invasive procedures and to save Medicare and other insurers over $100 million in unnecessary diagnostic testing each year in the U.S.
- Conditions
- Acute Coronary Syndrome
- Being tested
- PREtest Consult
- Keywords
- Acute Coronary Syndrome, Emergency Department, Chest Pain Evaluation Unit, Overtesting, Chest Pain Protocol, Myocardial Infarction, Medical Malpractice
- Medical subject headings
- Acute Coronary Syndrome, Emergencies, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREtest ConsultDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Documented myocardial infarction (ESC criteria)
Death thought to be from ACS (autopsy not required)
Need for revascularization (stent or surgical) within 45 days
Cardiac catheterization demonstrating
Secondary outcomes (7)
Percentage of patients deemed very low risk (pretest probability less than 2%) by the physician or the PREtest Consult ACS platform during the index visit
Percentage of patients discharged without admission to the hospital or emergency department chest pain unit during the index visit
Length of stay for the index visit to the emergency department
Incidence of stress testing, cardiac imaging and cardiac catheterization during the index visit and in the 45 days following the index visit
Hospital charges billed to each patient or their insurance provider for the index visit
Rate of reimbursement to the hospital for the index visit of each patient
Patient satisfaction as recorded by a survey instrument during a phone interview seven (7) days post-index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2005 (estimated)
- Study startOct 2005
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PREtest Consult
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeffrey A Kline, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243516
- Sponsor's protocol ID
- 1
- Status last verified
- Sep 2006
- First submitted
- 17 Oct 2005
- Last updated
- 9 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial for the Use of Pretest Probability to Reduce Unnecessary Testing for Low-Risk Patients With Chest Pain
- ClinicalTrials.gov ID
- NCT00243516
- Acronym / sponsor ID
- 1
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome, Emergency Department, Chest Pain Evaluation Unit, Overtesting, Chest Pain Protocol, Myocardial Infarction, Medical Malpractice
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- PREtest ConsultIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Oct 2007
- First posted
- 24 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate if the implementation of quantitative pretest probability assessment will significantly reduce the unnecessary use of the intra-emergency department chest pain center. Specifically, the study will examine whether the PREtest Consult acute coronary syndrome (ACS) pretest probability assessment system can significantly reduce the use of chest pain unit evaluation in very low risk emergency department (ED) patients, can safely discharge patients with a pretest probability ≤ 2.0%, can reduce unnecessary procedures and lower hospital costs and will examine patient satisfaction of patients with whom pretest probability assessment was used compared to those with whom it was not used.
The researchers hypothesize that patients in the control group of the study will have statistically significant reductions in mean time spent in the emergency department, mean charges billed to the patient or their insurance carrier, hospital length of stay, mean number of procedures or tests performed without a statistically significant change in patient satisfaction or adverse outcome.
Detailed description
Chest pain represents the second most frequent complaint among the 110 million persons who visit emergency departments in the U.S. each year. Perceived medicolegal risk compels emergency physicians to overtest for possible acute coronary syndrome (ACS), contributing to more than $20 billion in unnecessary diagnostic testing each year. The hypothesis of the present work states that quantitative pretest probability assessment can significantly and safely increase the proportion of very low risk patients with symptoms of ACS who are discharged from one emergency department. Quantitative pretest probability will be assessed with the validated, commercially available PREtest Consult ACS software device, which employs computer assisted, attribute matching. This method matches an 8-component clinical profile from any individual patient to the same profile shared by patients who were previously evaluated for ACS and whose profiles are stored in a 14,800 patient reference database. Pretest probability estimates ≤ 2% will be considered "test negative." A phase II multicenter study found that when the ACS PREtest Consult produced a pretest probability of ACS ≤ 2.0% that the actual outcome of ACS at 45 days was 0.3% (95% CI 0 to 1.8%) compared with 0.4% (0 to 0.9%) for patients discharged after negative testing in a chest pain unit (CPU) that included serial biomarkers, overnight monitoring, and cardiologist-interpreted provocative testing. Over one-quarter of all patients referred to the CPU had an estimate ≤ 2%. The present study will randomize 400 ED patients with a non-diagnostic or normal ECG and a troponin test ordered into two groups:
- a "show me", or disclosure group, in which patients and their clinicians will receive the output of the device, and
- a "no show" or concealed group will receive no output.
The sample size will detect an 11.5% difference in rate of discharge between groups with α = 0.05 and β = 0.20. All discharged patients will undergo structured telephone and medical record follow-up at 7 and 45 days using validated methodology.
Primary outcome measures will evaluate the development of acute coronary syndrome.
Secondary variables will include:
- Frequency of ACS, determined by blinded adjudicated review of follow-up data,
- Rate of return to any ED for similar symptoms,
- Patient satisfaction,
- Charges.
Project significance includes the potential to reduce patient exposure to unnecessary invasive procedures and to save Medicare and other insurers over $100 million in unnecessary diagnostic testing each year in the U.S.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Emergency department patients aged > 17 who report a history of torso or arm discomfort within the past 24 hours.
- Physician orders an electrocardiogram and serum troponin measurement.
- Physician has undergone a 10 minute explanation session and has provided consent
Key exclusion criteria (9 listed)
- 12-lead electrocardiogram (ECG) with ST deviation or T-wave changes that are interpreted by clinician as indicative of acute infarction or ischemia
- "Code STEMI" patients (patients with suspected acute myocardial infarction).
- Other primary diagnosis mandating admission (e.g., pneumonia, diabetic ketoacidosis, trauma)
- Patients with myocardial infarction, intracoronary stent placement, or coronary artery bypass grafting within the previous 30 days.
- Evidence of circulatory shock (SBP [systolic blood pressure] < 100 mmHg with symptoms defined by Jones)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PREtest Consult | Device | – |
Primary outcome
Documented myocardial infarction (ESC criteria)
Death thought to be from ACS (autopsy not required)
Need for revascularization (stent or surgical) within 45 days
Cardiac catheterization demonstrating
7 secondary outcomes
Percentage of patients deemed very low risk (pretest probability less than 2%) by the physician or the PREtest Consult ACS platform during the index visit
Percentage of patients discharged without admission to the hospital or emergency department chest pain unit during the index visit
Length of stay for the index visit to the emergency department
Incidence of stress testing, cardiac imaging and cardiac catheterization during the index visit and in the 45 days following the index visit
Hospital charges billed to each patient or their insurance provider for the index visit
Rate of reimbursement to the hospital for the index visit of each patient
Patient satisfaction as recorded by a survey instrument during a phone interview seven (7) days post-index visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2007.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey A Kline, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PREtest Consult in people with Acute Coronary Syndrome, run by PREtest Consult at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William B Webb, BSPH (704-355-0602, bwebb@pretestconsult.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documented myocardial infarction (ESC criteria). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2007.